by Nhi Dam / preview mode read

The Importance of Maintenance Performance in the Medical Device Manufacturing today

Medical Device Manufacturing consists not only of the process of designing, fabricating medical devices but also the aftermath quality control and maintenance performance. Since the medical device market is shifting towards a more value-driven landscape, and it is crucial to have the best quality devices since they directly affect humans’ lives, maintenance performance is of utmost importance.

In 2022, the market size of Medical Device Manufacturing is 49.1 billion dollars in the US, increasing by 1.5% from 2017. This is a large market and the demand for it is ever-increasing thanks to the rise of the pandemic. Manufacturers, hence, face the challenge of becoming more efficient, cost-effective, secure, and innovative.

How important is maintenance performance in Medical Device Manufacturing?

Maintenance performance is critical in this industry because lives are dependent on the performance of the devices. Furthermore, improper maintenance can lead to downtime in medical devices, which is not only critical to patients’ conditions but also costs a lot. 

Medical device manufacturers may not be able to afford the cost of these downtimes because it is a humongous amount. For example, an automotive manufacturer’s downtime can cost up to 22,000 dollars per minute on average. Especially during high-demand periods like the pandemic, manufacturers cannot afford and keep up with these expenses.

Thus, it is of utmost importance to not only spot potential failures before launching the devices but also have a good process for quality maintenance afterward.

It directly affects humans' lives
It directly affects humans' lives (Source: Internet)

Good Manufacturing Practices are essential

Medical manufacturers must ensure that they strictly follow Good Manufacturing Practices (GMP). Such practices are made so that the government can check the safety and quality of medical devices before they are distributed.

By following GMP, medical devices are proven to function better in performance and maintenance, step one to ensure maintenance performance. It reduces the failure risks and other concerns. 

Good manufacturing practice is important
Good manufacturing practice is important (Source: Internet)

Ways to improve maintenance performance for Medical Device Manufacturing

However, the GMP is not enough and is only performed by manufacturers. There are still a lot of risks and things to keep in mind for maintenance performance when you use medical devices. Here are some suggestions to improve maintenance performance: 

Track maintenance metrics

It is difficult to know what to check to ensure maintenance performance for medical devices. Therefore, there have been some readily designed metrics, created by professionals to help you with the process. Here are some examples: Planned Maintenance Percentage (PPC), Mean Time Between Failure (MTBF), Preventive Maintenance Compliance (PMC) and Mean Time to Repair (MTTR). 

These metrics assist you with making real use of the data. Information converted from data after using these metrics will tell you the performance of the devices and what, when, and how you should keep an eye out for. 

Use predictive maintenance

As the saying goes, “prevention is better than cure”, predictive maintenance techniques will evaluate the devices and predict when you need maintenance. This requires a thorough understanding of the machines and why they fail and provides warning signs when the devices are about to have downtime so you can take preemptive measures. 

By offering ways to prevent possible failures, the predictive maintenance method enhances safety compliance and asset longevity.

Spend more time in training

A 2018 maintenance survey points out that operator errors cause 18% of unscheduled downtime. A study generated by the American Society for Training and Development claims that formal training for staff members can actually increase productivity by 230% compared to untrained workers. 

Having proper training means staff knows how to handle the devices in the right way and with the predictive maintenance method they can tell when the medical instruments are about to have downtime to call for technicians or handle them by themselves.

Performing an audit to improve efficiency 

Managing medical devices has never been easy and it has become more and more complex in recent years thanks to many technological advancements, the sophistication of the devices, dependence on external sources for maintenance, and increasing demand for safety compliance, reliability, and accuracy.

Healthcare professionals can analyze the techniques they use in management programs and ways to improve maintenance by using medical equipment historical data and carrying out an equipment audit.

Baselines and methodology

Before starting, professionals recommend establishing a baseline, for example, by calculating their biomedical equipment program’s cost of service (COS) ratio. It was developed by Ted Cohen, a clinical engineering manager to determine the financial effectiveness of a biomedical maintenance program.

There have been a variety of medical management programs over the past 25 years that develop methodologies from fix-it-when-it-is broken to preventive methods.

Analyzing a program

Most current preventive programs are not adequate in terms of data. There is a need for new data input and reorganization so that the process of maintenance could go more smoothly. Technicians, who are in charge of the facilities, should provide the following information about the facilities: their current process, new process, steps to achieve the new process, and expected goals. All of these should be followed up and revisited regularly to ensure the maintenance process.

Though it seems exhausting to manage all of this data, most of it is already available in the maintenance system. However, most of the time, information is not linked together so tracking can be tricky. Also, some information like planned operational time, needs only to be entered once. Professionals should work closely with technical staff to export valuable reports or to be assisted with programming and training support to use the database. 

Performing an inventory 

To use such valuable data, professionals must create an inventory of all the medical facilities. The list must be comprehensive, including not only obvious details like manufacturer and asset number but also relevant information for maintenance such as function, utility, breakdown frequency, downtime cost, etc.

Such comprehensive information may take a lot of time and effort to build up. Medical professionals should work closely with a technological staff and build it over time, breaking up the process into smaller bits. Having such inventory allows easy documentation, analysis, and predictive measures.  

Working information 

To put information into use, professionals can organize it according to the following categories: 

  • Increased efficiency
  • Equipment replacement
  • Outsourcing
  • Informatics
  • Maintenance frequency
  • Finding user errors

Savings and efficiency

By performing a complete medical facilities inventory audit, professionals can cut costs and increase the efficiency of the maintenance process. The database built from such information provides cues for repair cost reduction, prediction of downtime failure, and foretelling signs of user errors. Facilities managers will also be able to use quantitative data to aid in short- and long-term strategic equipment planning.

Managing medical facilities’ maintenance performance can be strenuous. Though there are several ways, and steps are listed for each way, professionals might still find it hard to take the load. If so, reach out to maintenance services that are listed in this article.

Performing an audit is one of the ways to improve maintenance performance
Performing an audit is one of the ways to improve maintenance performance (Source: Internet)

Need some tips? We’re here to help

Are you struggling to manage medical facilities’ maintenance performance? Follow our directions above to see some incredible results. 

In case you need to research more on the topic of healthcare, at, we provide you with resourceful articles on it.

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Nhi Dam

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